The present invention generally relates to an oral dietary supplement which decreases serum insulin levels. High levels of serum insulin (i.e., hyperinsulinemia) is a major health problem. Hyperinsulinemia promotes hypertension, suppresses the release of growth hormone, and can harm the kidneys. The vascular system can be severely damaged by prolonged exposure to high insulin levels. Excess insulin can also increase the risk and progression of certain cancers and is a contributory factor in benign prostate enlargement.
High serum insulin is associated with the development of obesity and a large number of related health problems including degenerative joint disease, atherosclerosis, and impotence. Specifically, obesity has been associated with excess insulin production and reduced insulin sensitivity which are both risk factors for Type II diabetes. Therefore, obese individuals face a significant risk for developing Type II diabetes. It is possible to mitigate or control either Type II diabetes or obesity by effectively controlling the other.
There has been an increasing incidence of obesity in our society and an absence of effective weight control. The role of hyperinsulinemia in the origin and maintenance of idiopathic obesity is well established. It is widely known in the medical community that an increase in fasting insulin is the critical difference between thin and obese persons. Specifically, fat cannot be released from storage as long as insulin is present in the blood. This may be why dieting alone, i.e. caloric restriction, has not been effective in controlling obesity. When insulin is circulating in the blood stream, the body will not release significant fat stores, even when a person exercises and restricts their food intake. Such circumstances would only result in the loss of lean body mass and fluid.
In normal healthy individuals, insulin blood levels fall to zero when the serum glucose level drops below approximately 83 mg %. In obese individuals, insulin blood levels rarely fall to zero. As little as one microunit of insulin in serum will prevent the breakdown of stored fat. Even starvation does not bring insulin levels to normal in obese subjects.
As people age, sensitivity of cells to insulin generally decreases due to sedentary lifestyles, poor diet, and the natural aging process. The pancreatic response to this is often hyper-secretion of insulin. Therefore, it is difficult for people to lose a significant amount of body fat as long as they suffer from insulin overload. A noticeable effect of excess serum insulin is constant hunger. This results in a vicious cycle where overeating causes more body fat to accumulate and in turn, causes greater amounts of insulin secretion. The most immediate and noticeable effect of too much insulin may be unwanted weight gain.
Mannoheptulose is a seven carbon sugar which is naturally found in avocado fruit. Mannoheptulose inhibits hexokinase in a predominantly competitive manner. Hexokinase is an enzyme which catalyzes the phosporylation glucose to glucose -6-phosphate (G6P), which is the first reaction of glycolysis. Therefore, ingestion of mannoheptulose is a logical method of decreasing insulin serum levels.
Previously, the potential usefulness of this seven-carbon ketogenated sugar has been limited by its unpleasant side effects (e.g., diarrhea, nausea) and poor absorption on oral administration. There are problems with unpleasant side-effects, and problems of transient hypoglycemia. Scientists have believed that orally administered mannoheptulose was limited to the extent which it could be absorbed in man, because of its laxative effect when orally administered. This effect is most likely an osmotic effect, similar to that of mannitol. Mannoheptulose has been shown to lower fasting and glucose stimulated peak insulin release in mammals including man.
The only oral pharmaceutical preparation available for hyperinsulinemia is diazoxide (sold under the tradename Proglycem®). which is also sold as an intravenous anti-hypertensive (sold under the tradename Hyperstat®). However, its usefulness has been limited by its significant side-effects and serious drug interactions. Treatment of obese patients with diazoxide lowers insulin levels, but also drops blood pressure dangerously and can intensify the effects of anticoagulants. The diazoxide intravenous solution must be administered with great care so as to not inject it subcutaneously, intramuscularly or into body cavities. Extravasation must be avoided because the solution is alkaline and very irritating.
Many features, advantages, and objects of the present invention will become apparent to one with skill in the art upon examination of the detailed description. It is intended that all such features, advantages, and objects be included herein within the scope of the present invention.